Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 087811
Company: VALEANT
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PHRENILIN ACETAMINOPHEN; BUTALBITAL 325MG;50MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL Discontinued None No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
06/19/1985 ORIG-1 Approval

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
12/13/2014 SUPPL-29 Labeling-Package Insert

Label is not available on this site.

08/10/2011 SUPPL-28 Labeling-Package Insert

Label is not available on this site.

06/03/2003 SUPPL-25 Labeling

Label is not available on this site.

12/06/2001 SUPPL-23 Manufacturing (CMC)-Facility

Label is not available on this site.

07/25/2001 SUPPL-22 Manufacturing (CMC)-Control

Label is not available on this site.

07/25/2001 SUPPL-21 Manufacturing (CMC)-Facility

Label is not available on this site.

04/26/1996 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

04/28/1997 SUPPL-19 Labeling

Label is not available on this site.

04/28/1997 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

09/29/1994 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

06/10/1994 SUPPL-16 Labeling

Label is not available on this site.

12/07/1993 SUPPL-15 Labeling

Label is not available on this site.

05/15/1992 SUPPL-14 Labeling

Label is not available on this site.

05/08/1992 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

08/04/1992 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

07/01/1992 SUPPL-11 Labeling

Label is not available on this site.

03/27/1992 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

03/27/1992 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

10/05/1989 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

10/05/1989 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

04/07/1989 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

04/07/1989 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

04/07/1989 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

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